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30/09/2022 Human medicines European public assessment report (EPAR): Amlodipine / Valsartan Mylan , Amlodipine besilate, valsartan, Hypertension, 22/03/2016, Generic, 10, Authorised
30/09/2022 Human medicines European public assessment report (EPAR): Ogivri, trastuzumab, Stomach Neoplasms; Breast Neoplasms, 12/12/2018, Additional monitoring, Biosimilar, 9, Authorised
30/09/2022 Methodology Working Party
30/09/2022 3Rs Working Party
30/09/2022 Non-clinical Working Party
30/09/2022 Orphan designation: (S)-3-((3-(1-((6-(3,4-dimethoxyphenyl)pryazin-2-yl)amino)ethyl)phenyl)carbamoyl)-5-methylpridin-1-ium (seralutinib) for the: Treatment of pulmonary arterial hypertension, 29/05/2019, Positive
30/09/2022 News and press releases: Regulatory information – adjusted fees for pharmacovigilance applications from 3 October 2022
30/09/2022 Other: Explanatory note on pharmacovigilance fees payable to EMA (as of 3 October 2022)
30/09/2022 Product Management Services (PMS) Sub-Groups (SG) Webinar , Online, from 09/09/2022 to 09/09/2022
30/09/2022 Orphan designation: Setmelanotide for the: Treatment of Bardet-Biedl syndrome, 21/08/2019, Positive
30/09/2022 Periodic safety update single assessment: Loratadine / pseudoephedrine : List of nationally authorised medicinal products - PSUSA/00001908/202202
30/09/2022 News and press releases: New recommendations for terlipressin-containing medicines in the treatment of hepatorenal syndrome
30/09/2022 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26-29 September 2022
30/09/2022 Other: Procedural advice for post-orphan medicinal product designation activities: Guidance for sponsors
30/09/2022 Periodic safety update single assessment: Cromoglicic acid : List of nationally authorised medicinal products - PSUSA/00000883/202202
30/09/2022 Periodic safety update single assessment: Loratadine : List of nationally authorised medicinal products - PSUSA/00001907/202202
30/09/2022 Periodic safety update single assessment: Influenza vaccine (surface antigen, inactivated) : List of nationally authorised medicinal products - PSUSA/00001744/202203
30/09/2022 Periodic safety update single assessment: Influenza vaccine (split virion, inactivated) (non centrally authorised products) : List of nationally authorised medicinal products - PSUSA/00010298/202203
30/09/2022 Periodic safety update single assessment: Zanamivir (except for centrally authorised products) : List of nationally authorised medicinal products - PSUSA/00003141/202201
30/09/2022 Human medicines European public assessment report (EPAR): Nulibry, fosdenopterin hydrobromide dihydrate, Metal Metabolism, Inborn Errors, 15/09/2022, Orphan, Additional monitoring, Authorised
30/09/2022 Report: Medicinal products for human use: monthly figures - August 2022
30/09/2022 Other: Organisation chart: Advisory functions
30/09/2022 Advisory functions
30/09/2022 Orphans: Regulatory and procedural guidance and forms
29/09/2022 Periodic safety update single assessment: Alverine / simeticone : List of nationally authorised medicinal products - PSUSA/00000125/202202
29/09/2022 News and press releases: EMA pilot offers enhanced support to academic and non-profit developers of advanced therapy medicinal products
29/09/2022 Other: Procedural advice for requests for the classification of variations not already listed in Commission Implementing Regulation (EU) 2021/17 or EMA/CMDv guidance on the details of the classification of variations requiring assessment according to Article 62
28/09/2022 Human medicines European public assessment report (EPAR): Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop), irbesartan, hydrochlorothiazide, Hypertension, 18/01/2007, 33, Authorised
28/09/2022 Orphan designation: Variant of recombinant human fibroblast growth factor 19 for the: Treatment of primary sclerosing cholangitis, 14/12/2015, Positive
28/09/2022 Orphan designation: Adeno-associated viral vector serotype 5 containing a B-domain deleted variant of human coagulation factor VIII gene for the: Treatment of haemophilia A, 21/03/2016, Positive
28/09/2022 Orphan designation: human anti-promyostatin monoclonal antibody (apitegromab) for the: Treatment of spinal muscular atrophy, 14/12/2018, Positive
28/09/2022 Orphan designation: Recombinant adeno-associated viral vector containing the human CNGB3 gene for the: Treatment of achromatopsia caused by mutations in the CNGB3 gene, 08/02/2013, Positive
28/09/2022 Orphan designation: Combretastatin A1 diphosphate for the: Treatment of acute myeloid leukaemia, 14/12/2015, Positive
28/09/2022 Human medicines European public assessment report (EPAR): Fasenra, benralizumab, Asthma, 08/01/2018, 9, Authorised
28/09/2022 Other: Questions and answers on describing adverse events in the product information (summary of product characteristics (SPC) and package leaflet (PL))
28/09/2022 Direct healthcare professional communication (DHPC): Direct healthcare professional communication (DHPC): NULOJIX (belatacept): Further extension of the temporary restriction in supply up until 3Q 2023, Active substance: belatacept, DHPC type: Medicine shortage, Last updated: 28/09/2022
28/09/2022 Template or form: QRD product-information template version 10.3 - highlighted
28/09/2022 Product-information templates - Human
28/09/2022 Template or form: QRD product-information template version 10.3
28/09/2022 Template or form: QRD product-information annotated template (English) version 10.3
28/09/2022 Template or form: QRD product-information annotated template (English) version 10.3 - highlighted
28/09/2022 Template or form: QRD Appendix V - Adverse-drug-reaction reporting details
28/09/2022 Template or form: Specimen submission form
28/09/2022 Human medicines European public assessment report (EPAR): Irbesartan Zentiva (previously Irbesartan Winthrop), irbesartan, Hypertension, 19/01/2007, 28, Authorised
28/09/2022 Withdrawn application: Imcivree, setmelanotide, Date of withdrawal: 22/04/2022, Post-authorisation
28/09/2022 Periodic safety update single assessment: Triamcinolone (intraocular formulations) : List of nationally authorised medicinal products - PSUSA/00010292/202103
28/09/2022 Periodic safety update single assessment: Ofloxacin (topical use) : List of nationally authorised medicinal products - PSUSA/00002204/202104
28/09/2022 Orphan designation: Ilixadencel for the: Treatment of gastrointestinal stromal tumours, 26/03/2021, Positive
28/09/2022 Regulatory and procedural guideline: Checking process of mock-ups and specimens of outer / immediate labelling and package leaflets of human medicinal products in the centralised procedure
27/09/2022 Regulatory and procedural guideline: Good practice guide for the use of the Metadata Catalogue of Real-World Data Sources
27/09/2022 Human medicines European public assessment report (EPAR): Skilarence, dimethyl fumarate, Psoriasis, 23/06/2017, 11, Authorised
27/09/2022 Human medicines European public assessment report (EPAR): Lemtrada, alemtuzumab, Multiple Sclerosis, 12/09/2013, Additional monitoring, 20, Authorised
27/09/2022 Human medicines European public assessment report (EPAR): Tukysa, Tucatinib, Breast Neoplasms; Neoplasm Metastasis, 11/02/2021, Additional monitoring, 2, Authorised
27/09/2022 Human medicines European public assessment report (EPAR): Trizivir, abacavir (as sulfate), lamivudine, zidovudine, HIV Infections, 27/12/2000, 42, Authorised
27/09/2022 Human medicines European public assessment report (EPAR): Hemlibra, Emicizumab, Hemophilia A, 23/02/2018, Accelerated assessment, Additional monitoring, 12, Authorised
27/09/2022 Human medicines European public assessment report (EPAR): Vaxchora, vibrio cholerae, strain cvd 103-hgr, live, Cholera, 01/04/2020, Additional monitoring, 6, Authorised
27/09/2022 Human medicines European public assessment report (EPAR): Zalviso, sufentanil, Pain, Postoperative, 18/09/2015, 7, Withdrawn
27/09/2022 Veterinary Medicinal Products Regulation
27/09/2022 Minutes: Minutes of the CHMP meeting 18-21 July 2022
27/09/2022 Human medicines European public assessment report (EPAR): Reblozyl, Luspatercept, Anemia; Myelodysplastic Syndromes; beta-Thalassemia, 25/06/2020, Orphan, Additional monitoring, 3, Authorised
27/09/2022 Withdrawn application: HemAryo, eptacog alfa (activated), Date of withdrawal: 06/05/2022, Initial authorisation
26/09/2022 Human medicines European public assessment report (EPAR): Vaniqa, Eflornithine, Hirsutism, 19/03/2001, 23, Authorised
26/09/2022 Union Pharmacovigilance Database: refresher webinar on signal management overview , Online, 10:00-12:00 Amsterdam time (CET), from 27/10/2022 to 27/10/2022
26/09/2022 Herbal medicinal product: Camelliae sinensis non fermentatum folium, Camelliae sinensis non fermentatum folium, F: Assessment finalised
26/09/2022 Human medicines European public assessment report (EPAR): Atazanavir Mylan, atazanavir (as sulfate), HIV Infections, 22/08/2016, Generic, 12, Authorised
26/09/2022 Orphan designation: Autologous CD34+ cells transduced with lentiviral vector encoding the human beta globin gene for the: Treatment of beta thalassaemia intermedia and major, 30/05/2016, Positive
26/09/2022 Agenda: Agenda of the PRAC meeting 26-29 September 2022
26/09/2022 Orphan designation: Ofranergene obadenovec for the: Treatment of ovarian cancer, 16/10/2017, Positive
26/09/2022 Orphan designation: Adenovirus-associated vector containing human Fas-c gene (ofranergene obadenovec) for the: Treatment of glioma, 06/06/2012, Positive
26/09/2022 Human medicines European public assessment report (EPAR): Rixubis, nonacog gamma, Hemophilia B, 19/12/2014, 11, Authorised
26/09/2022 Human medicines European public assessment report (EPAR): Remicade, infliximab, Spondylitis, Ankylosing; Arthritis, Rheumatoid; Psoriasis; Crohn Disease; Arthritis, Psoriatic; Colitis, Ulcerative, 13/08/1999, 61, Authorised
26/09/2022 Availability of medicines
23/09/2022 Human medicines European public assessment report (EPAR): Kadcyla, trastuzumab emtansine, Breast Neoplasms, 15/11/2013, 14, Authorised
23/09/2022 Other: FAQs: How to create, submit and withdraw a Clinical Trial Application - CTIS Training Programme - Module 10
23/09/2022 News and press releases: New co-chairs elected for working parties for healthcare professionals and for patients and consumers
23/09/2022 Minutes: Minutes of the HMPC 18-20 July 2022 meeting
23/09/2022 Committee for Herbal Medicinal Products (HMPC): 18-20 July 2022 , from 18/07/2022 to 20/07/2022
23/09/2022 Risk management information day 2022 , Virtual meeting, from 09/12/2022 to 09/12/2022
23/09/2022 Human medicines European public assessment report (EPAR): Rydapt, Midostaurin, Leukemia, Myeloid, Acute; Mastocytosis, 18/09/2017, Orphan, 9, Authorised
23/09/2022 Human medicines European public assessment report (EPAR): Elzonris, tagraxofusp, Lymphoma, 07/01/2021, Orphan, Additional monitoring, Exceptional circumstances, 5, Authorised
23/09/2022 Direct healthcare professional communication (DHPC): Metalyse (tenecteplase) 8000 units (40 mg) and 10000 units (50 mg) powder and solvent for solution for injection: temporary supply shortage, Active substance: tenecteplase, DHPC type: Medicine shortage, Last updated: 23/09/2022
23/09/2022 Supply shortage: Shortage of Actilyse (alteplase) and Actilyse Cathflo (alteplase)
23/09/2022 Supply shortage: Shortage of Metalyse (tenecteplase)
23/09/2022 Scientific and technical recommendations: Veterinary Medicines Regulation
23/09/2022 Regulatory and procedural guideline: Implementing measures under Article 93(2) of Regulation (EU) 2019/6 as regards the good manufacturing practice for veterinary medicinal products and active substances used as starting materials
22/09/2022 Minutes: Minutes of the COMP meeting on 15-17 March 2022
22/09/2022 Human medicines European public assessment report (EPAR): Blincyto, blinatumomab, Precursor Cell Lymphoblastic Leukemia-Lymphoma, 23/11/2015, Orphan, Additional monitoring, 15, Authorised
22/09/2022 Orphan designation: Eltanexor for the: Treatment of myelodysplastic syndromes, 21/06/2022, Positive
22/09/2022 Orphan designation: Modified mRNA encoding human methylmalonyl-coenzyme A mutase containing a polymorphism at position 671 for the: Treatment of methylmalonic acidaemia, 21/06/2022, Positive
22/09/2022 Orphan designation: 2'-O-(2-methoxyethyl)-5-methyl-P-thiocytidylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methyl-P-thiouridylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methyl-P-thiouridylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methyl-P-thiouridylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methyl-P-thiocytidylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methyl-P-thiocytidylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methyl-P-thiouridylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methyl-P-thiouridylyl -(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methyl-P-thiocytidylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-P-thioadenylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methyl-P-thiocytidylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methyl-P-thiouridylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-P-thioguanylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methyl-P-thiouridylyl for the: Treatment of cystic fibrosis, 21/06/2022, Positive
22/09/2022 Orphan designation: Human allogeneic keratinocytes for the: Treatment of partial deep dermal and full thickness burns, 21/06/2022, Positive
22/09/2022 Orphan designation: 2'-O-(2-methoxyethyl) modified antisense oligonucleotide targeting UBE3A antisense transcript RNA for the: Treatment of Angelman syndrome, 21/06/2022, Positive
22/09/2022 Orphan designation: Sirolimus for the: Treatment of follicular lymphoma, 21/06/2022, Positive
22/09/2022 Orphan designation: Sirolimus for the: Treatment of lymphatic malformations, 21/06/2022, Positive
22/09/2022 Orphan designation: Lithium carbonate for the: treatment of TBR1-related disorder, 21/06/2022, Positive
22/09/2022 Orphan designation: Humanised IgG4 monoclonal antibody against A proliferation-inducing ligand for the: Treatment of primary IgA nephropathy, 21/06/2022, Positive
22/09/2022 Human medicines European public assessment report (EPAR): Nyxoid, Naloxone hydrochloride dihydrate, Opioid-Related Disorders, 09/11/2017, 7, Authorised
22/09/2022 Human medicines European public assessment report (EPAR): Polivy, polatuzumab vedotin, Lymphoma, B-Cell, 16/01/2020, Orphan, Additional monitoring, Conditional approval, 4, Authorised
21/09/2022 Human medicines European public assessment report (EPAR): Vitrakvi, larotrectinib sulfate, Abdominal Neoplasms, 19/09/2019, Additional monitoring, Conditional approval, 7, Authorised
21/09/2022 Organisation Management System (OMS) Trouble Shooting Session for CTIS users - July 2022 , Online, 14:00 - 15:00 Amsterdam time (CEST), from 21/07/2022 to 21/07/2022
21/09/2022 Annex to CHMP highlights: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 12-15 September 2022
21/09/2022 Human medicines European public assessment report (EPAR): Pemetrexed Pfizer (previously Pemetrexed Hospira), pemetrexed disodium, pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma, 19/11/2015, Generic, 14, Authorised
20/09/2022 Human medicines European public assessment report (EPAR): Carmustine Obvius, carmustine, Hodgkin Disease; Lymphoma, Non-Hodgkin, 18/07/2018, Generic, 7, Authorised
20/09/2022 Human medicines European public assessment report (EPAR): Ontruzant, trastuzumab, Stomach Neoplasms; Breast Neoplasms, 15/11/2017, Biosimilar, 14, Authorised
20/09/2022 Human medicines European public assessment report (EPAR): Replagal, agalsidase alfa, Fabry Disease, 03/08/2001, 28, Authorised
20/09/2022 Extended EudraVigilance medicinal product dictionary (XEVMPD) training course for clinical trial sponsors - September 2022 , Online, 14:00 - 18:00 Amsterdam time (CEST) , from 29/09/2022 to 30/09/2022
20/09/2022 Human medicines European public assessment report (EPAR): Fortacin, lidocaine, prilocaine, Sexual Dysfunction, Physiological, 15/11/2013, 11, Authorised
20/09/2022 Other: Records of data processing activity of personal data in the context of public procurement procedures (public)
20/09/2022 Other: European Medicines Agency's Data Protection Notice for the processing of personal data in the context of public procurement procedures
20/09/2022 Agenda: Draft agenda - PCWP and HCPWP meeting - 22 September 2022
20/09/2022 Scientific guideline: Concept paper on the establishment of a guideline on the development and manufacture of synthetic peptides
20/09/2022 Establishment of a guideline on the development and manufacture of synthetic peptides - Scientific guideline
20/09/2022 Scientific guideline: Concept paper on the establishment of a guideline on the development and manufacture of synthetic oligonucleotides
20/09/2022 Establishment of a guideline on the development and manufacture of synthetic oligonucleotides - Scientific guideline
20/09/2022 Human medicines European public assessment report (EPAR): Tenofovir disoproxil Mylan, tenofovir disoproxil, HIV Infections, 08/12/2016, Generic, 16, Authorised
19/09/2022 Human medicines European public assessment report (EPAR): Palforzia, defatted powder of Arachis hypogaea L., semen (peanuts), Peanut Hypersensitivity, 17/12/2020, Additional monitoring, 5, Authorised
19/09/2022 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 September 2022
19/09/2022 News and press releases: Biosimilar medicines can be interchanged
19/09/2022 Agenda: Agenda of the HMPC meeting 19-21 September 2022
19/09/2022 Minutes: PDCO minutes of the 22-25 March 2022 meeting
19/09/2022 Agenda: Agenda of the PDCO meeting 19-22 April 2022
19/09/2022 Minutes: PDCO minutes of the 22-25 February 2022 meeting
19/09/2022 Human medicines European public assessment report (EPAR): Nepexto, etanercept, Arthritis, Rheumatoid; Arthritis, Juvenile Rheumatoid; Arthritis, Psoriatic; Spondylarthropathies; Spondylitis, Ankylosing; Psoriasis, 20/05/2020, Additional monitoring, Biosimilar, 7, Authorised
16/09/2022 Orphan designation: allogenic cytomegalovirus-specific cytotoxic T lymphocytes (adimlecleucel) for the: Treatment of cytomegalovirus infection in patients with impaired cell-mediated immunity, 18/11/2016, Withdrawn
16/09/2022 Orphan designation: Allogeneic CD34+ cells expanded ex vivo with an aryl hydrocarbon receptor antagonist (spanlecortemlocel) for the: Treatment of acute lymphoblastic leukaemia, 16/12/2014, Withdrawn
16/09/2022 Orphan designation: Autologous CD34+ cells transduced ex vivo with a lentiviral vector containing a modified gamma-globin gene for the: Treatment of sickle cell disease, 13/11/2020, Withdrawn
16/09/2022 Organisation Management System (OMS) Trouble Shooting Session for CTIS users - September 2022 , from 22/09/2022 to 22/09/2022
16/09/2022 Other: Questions and answers on labelling flexibilities for COVID-19 vaccines
16/09/2022 Orphan designation: Self-complementary adeno-associated viral vector serotype 9 containing the SGSH gene for the: Treatment of mucopolysaccharidosis, type IIIA (Sanfilippo A syndrome), 20/09/2016, Positive
16/09/2022 Other: Floseal haemostatic matrix (Floseal VH S/D) - Procedural steps and scientific information after initial consultation
16/09/2022 News and press releases: New medicine to protect babies and infants from respiratory syncytial virus (RSV) infection
16/09/2022 Summary of opinion: Brukinsa, zanubrutinib, 15/09/2022, Positive
16/09/2022 Other: Decision of the Management Board on amending budget No. 01, amending appropriations in budget 2022
16/09/2022 Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) , Online, 10:00 - 11:00 Amsterdam time (CEST), from 02/09/2022 to 02/09/2022
16/09/2022 Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) , Online, 15:00 - 16:00 Amsterdam time (CEST), from 25/07/2022 to 25/07/2022
16/09/2022 News and press releases: EMA recommends standard marketing authorisations for Comirnaty and Spikevax COVID-19 vaccines
16/09/2022 Ad-hoc meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) , Online, 10:30-12:30 Amsterdam time (CEST), from 07/07/2022 to 07/07/2022
16/09/2022 Antimicrobial-resistance surveillance as post-marketing authorisation commitment - Scientific guideline
16/09/2022 Scientific guideline: Concept paper on a guideline on data requirements for post-authorisation studies for antimicrobial veterinary medicinal products under Article 36(2) of Regulation (EU) 2019/6
16/09/2022 Minutes: Minutes of the CVMP meeting of 12-14 July 2022
15/09/2022 Human medicines European public assessment report (EPAR): Tenofovir disoproxil Zentiva, tenofovir disoproxil phosphate, HIV Infections, 15/09/2016, Generic, 12, Authorised
15/09/2022 Human medicines European public assessment report (EPAR): Sialanar, glycopyrronium bromide, Sialorrhea, 15/09/2016, 9, Authorised
15/09/2022 Regulatory and procedural guideline: List of changes to combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse reactions in animal and humans to veterinary medicinal products
15/09/2022 Regulatory and procedural guideline: Combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products
15/09/2022 Regulatory and procedural guideline: Combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products (Excel)
15/09/2022 Regulatory and procedural guideline: Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) dataload friendly file including deprecated terms
15/09/2022 Orphan designation: Sodium (4Z,7Z,10R,11E,13E,15Z,17S,19Z)10,17-dihydroxy-docosa-4,7,11,13,15,19-hexaenoate for the: Prevention of retinopathy of prematurity, 21/06/2022, Positive
15/09/2022 Orphan designation: Pirfenidone for the: Treatment of idiopathic pulmonary fibrosis, 24/06/2022, Positive
15/09/2022 Orphan designation: 4-[[(3S)-1-benzylpyrrolidin-3-yl]-methylamino]-2-fluoro-5-methyl-N-(1,3-thiazol-4-yl)benzenesulfonamide for the: Treatment of SCN8A developmental and epileptic encephalopathy, 21/06/2022, Positive
15/09/2022 Webinar on requesting access to and using EMA's substance, product, organisation and referential (SPOR) application programming interface (API) , Online, 14:00 - 16:00 Amsterdam time (CEST), from 11/10/2022 to 11/10/2022
15/09/2022 Orphan designation: 3-(1-(2',3'-dimethoxy-[1,1'-biphenyl]-4-yl)-1H-1,2,3-triazol-4-yl)benzoic acid for the: Treatment of gain-of-function mutations of STIM1 and ORAI1 related diseases, 21/06/2022, Positive
15/09/2022 Orphan designation: ropeginterferon alfa-2b for the: Treatment of chronic myeloid leukaemia, 21/06/2022, Positive
15/09/2022 Orphan designation: amitriptyline for the: Treatment of erythromelalgia, 21/06/2022, Positive
15/09/2022 Human medicines European public assessment report (EPAR): Yellox, bromfenac sodium sesquihydrate, Pain, Postoperative; Ophthalmologic Surgical Procedures, 18/05/2011, 11, Authorised
15/09/2022 Orphan designation: Allogeneic human dendritic cells derived from a CD34+ progenitor cell line for the: Treatment of acute myeloid leukaemia, 22/05/2012, Positive
15/09/2022 Orphan designation: Allogeneic faecal microbiota, pooled for the: Treatment of graft-versus-host disease, 19/11/2018, Positive
15/09/2022 Orphan designation: Sebetralstat for the: Treatment of hereditary angioedema, 21/06/2022, Positive
15/09/2022 Orphan designation: Doxorubicin for the: Treatment of soft tissue sarcoma, 21/06/2022, Positive
15/09/2022 Orphan designation: losartan for the: Treatment of osteogenesis imperfecta, 21/06/2022, Positive
15/09/2022 Orphan designation: Escherichia coli, strain Nissle 1917, expressing high affinity phenylalanine transporter, phenylalanine ammonia lyase and L-amino acid deaminase for the: Treatment of hyperphenylalaninaemia, 21/06/2022, Positive
15/09/2022 Opinion on medicine for use outside EU: Dapivirine Vaginal Ring 25 mg, dapivirine, Anti-HIV Agents, 23/07/2020, Positive opinion
14/09/2022 Human medicines European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, efavirenz, emtricitabine, tenofovir disoproxil maleate, HIV Infections, 05/09/2017, Generic, 13, Authorised
14/09/2022 Orphan designation: budesonide for the: Treatment of primary IgA nephropathy, 18/11/2016, Positive
14/09/2022 Orphan designation: 17α,21-Dihydroxy-16α-methyl-pregna-1,4,9(11)-triene-3,20-dione (vamorolone) for the: Treatment of Duchenne muscular dystrophy, 22/08/2014, Positive
14/09/2022 Orphan designation: Modified mRNA encoding the UGT1A1 protein for the: Treatment of Crigler-Najjar syndrome, 27/06/2016, Positive
14/09/2022 Referral: Veterinary medicinal products containing N-methyl pyrrolidone as an excipient , Article 82, Under evaluation, 11/05/2022, 14/09/2022
14/09/2022 Orphan designation: Radio-iodinated (131I) anti-CD45 murine monoclonal antibody for the: Treatment in haematopoietic stem cell transplantation, 14/10/2016, Positive
14/09/2022 Opinion/decision on a Paediatric investigation plan (PIP): abelacimab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0127/2022
14/09/2022 Opinion/decision on a Paediatric investigation plan (PIP): Giroctocogene fitelparvovec, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0332/2021
14/09/2022 Opinion/decision on a Paediatric investigation plan (PIP): cenobamate, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0300/2021
14/09/2022 Opinion/decision on a Paediatric investigation plan (PIP): Lebrikizumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0286/2021
14/09/2022 Opinion/decision on a Paediatric investigation plan (PIP): Phenobarbital, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0301/2021
14/09/2022 Human medicines European public assessment report (EPAR): PritorPlus, telmisartan, hydrochlorothiazide, Hypertension, 22/04/2002, 37, Authorised
14/09/2022 Human medicines European public assessment report (EPAR): Kinzalkomb, telmisartan, hydrochlorothiazide, Hypertension, 19/04/2002, 39, Authorised
13/09/2022 Human medicines European public assessment report (EPAR): Tysabri, natalizumab, Multiple Sclerosis, 27/06/2006, 40, Authorised
13/09/2022 Fifth European Medicines Agency - Medicines for Europe bilateral meeting , Virtual meeting, from 15/09/2022 to 15/09/2022
13/09/2022 Agenda: Agenda - Fifth EMA-Medicines for Europe bilateral meeting
13/09/2022 Other: CTIS Training materials - Latest updates
13/09/2022 Opinion/decision on a Paediatric investigation plan (PIP): Sivopixant, W: decision granting a waiver in all age groups for all conditions or indications, P/0326/2021
13/09/2022 Opinion/decision on a Paediatric investigation plan (PIP): Gemcitabine (hydrochloride), W: decision granting a waiver in all age groups for all conditions or indications, P/0288/2021
13/09/2022 Opinion/decision on a Paediatric investigation plan (PIP): Cetrelimab, W: decision granting a waiver in all age groups for all conditions or indications, P/0289/2021
13/09/2022 Eight industry stakeholder platform on research and development support , Online, from 11/07/2022 to 11/07/2022
12/09/2022 Human medicines European public assessment report (EPAR): Cinacalcet Mylan, cinacalcet hydrochloride, Hyperparathyroidism, Secondary; Hypercalcemia, 19/11/2015, Generic, 14, Authorised
12/09/2022 Protection of personal data and commercially confidential information (CCI) for documents uploaded and published in the Clinical Trials Information System (CTIS): Workshop on draft guidance , Online, 10:00-17:00 Amsterdam time (CEST), from 14/07/2022 to 14/07/2022
12/09/2022 Opinion/decision on a Paediatric investigation plan (PIP): Ramipril,amlodipine,hydrochlorothiazide, W: decision granting a waiver in all age groups for all conditions or indications, P/0297/2021
12/09/2022 Human medicines European public assessment report (EPAR): Libmeldy, atidarsagene autotemcel, Leukodystrophy, Metachromatic, 17/12/2020, Orphan, Additional monitoring, 5, Authorised
12/09/2022 Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use'
12/09/2022 Opinion/decision on a Paediatric investigation plan (PIP): Immunoglobulin G1 anti-SORT1 human monoclonal antibody, W: decision granting a waiver in all age groups for all conditions or indications, P/0299/2021
12/09/2022 News and press releases: Adapted vaccine targeting BA.4 and BA.5 Omicron variants and original SARS-CoV-2 recommended for approval
12/09/2022 Other: Example files - production release version 1.6.8 September 2022 - Veterinary Medicinal Products Regulation: Union Product Database
12/09/2022 Other: Release notes - production release version 1.6.8 September 2022 - Veterinary Medicinal Products Regulation: Union Product Database
12/09/2022 Orphan designation: Efgartigimod alfa for the: Treatment of myasthenia gravis, 10/08/2022, Positive
12/09/2022 Opinion/decision on a Paediatric investigation plan (PIP): gabapentin, W: decision granting a waiver in all age groups for all conditions or indications, P/0335/2021
12/09/2022 Opinion/decision on a Paediatric investigation plan (PIP): Insulin icodec,semaglutide, W: decision granting a waiver in all age groups for all conditions or indications, P/0312/2021
12/09/2022 PIP decision: P/0344/2021 : EMA decision of 12 August 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for epcoritamab (EMEA-002907-PIP01-20)
12/09/2022 Opinion/decision on a Paediatric investigation plan (PIP): Epcoritamab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0344/2021
12/09/2022 PIP decision: P/0330/2021 : EMA decision of 11 August 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for cefepime / zidebactam (EMEA-002892-PIP01-20)
12/09/2022 Opinion/decision on a Paediatric investigation plan (PIP): cefepime,zidebactam, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0330/2021
12/09/2022 Human medicines European public assessment report (EPAR): Tavlesse, Fostamatinib disodium, Thrombocytopenia, 09/01/2020, Additional monitoring, 5, Authorised
12/09/2022 Human medicines European public assessment report (EPAR): Apealea, paclitaxel, Ovarian Neoplasms, 20/11/2018, 6, Authorised
12/09/2022 Agenda: Agenda of the CHMP meeting 12-15 September 2022
12/09/2022 Direct healthcare professional communication (DHPC): Nulojix (belatacept): Risk of medication errors due to change in maintenance dose from 5 mg/kg to 6 mg/kg, Active substance: belatacept, DHPC type: Medication error, Last updated: 12/09/2022
09/09/2022 Human medicines European public assessment report (EPAR): Vipdomet, alogliptin benzoate, metformin hydrochloride, Diabetes Mellitus, Type 2, 18/09/2013, 10, Authorised
09/09/2022 Maximum Residue Limits - Summary of opinion: Praziquantel (all ruminants except bovine, Equidae, fin fish) - Summary opinion of the CVMP on the establishment of maximum residue limits
09/09/2022 Summary of opinion: Improvac, Gonadotropin releasing factor (GnRF) analogue-protein conjugate, 08/09/2022, Positive
09/09/2022 News and press releases: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 6-8 September 2022
09/09/2022 Other: CooperSurgical Inc ART Media - Procedural steps and scientific information after initial consultation
09/09/2022 Periodic safety update single assessment: Pilocarpine (ophthalmic formulation) : List of nationally authorised medicinal products - PSUSA/00002410/202108
09/09/2022 Human medicines European public assessment report (EPAR): Incresync, alogliptin, pioglitazone, Diabetes Mellitus, Type 2, 19/09/2013, 13, Authorised
09/09/2022 Periodic safety update single assessment: Flumazenil : List of nationally authorised medicinal products - PSUSA/00001413/202112
09/09/2022 Human medicines European public assessment report (EPAR): Erelzi, etanercept, Arthritis, Psoriatic; Psoriasis; Arthritis, Juvenile Rheumatoid; Arthritis, Rheumatoid; Spondylitis, Ankylosing, 23/06/2017, Additional monitoring, Biosimilar, 12, Authorised
08/09/2022 Opinion/decision on a Paediatric investigation plan (PIP): Allogeneic anti-CD19 CAR T cells produced using CRISPR/Cas9 to disrupt the T cell receptor alpha constant (TRAC) and β2-microglobulin (B2M) genomic loci and a recombinant adeno-associated viral vector to deliver donor template for insertion of the anti-CD19 CAR expression cassette into the TRAC locus (CTX110), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0321/2021
08/09/2022 Opinion/decision on a Paediatric investigation plan (PIP): Afamitresgene autoleucel, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0323/2021
08/09/2022 Opinion/decision on a Paediatric investigation plan (PIP): (1R,3S,5R)-2-(2-(3-acetyl-5-(2-methylpyrimidin-5-yl)-1H-indazol-1-yl)acetyl)-N-(6-bromo-3- methylpyridin-2-yl)-5-methyl-2-azabicyclo[3.1.0]hexane-3-carboxamide (ALXN2050), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0324/2021
08/09/2022 Opinion/decision on a Paediatric investigation plan (PIP): Bentracimab, W: decision granting a waiver in all age groups for all conditions or indications, P/0290/2021
08/09/2022 Opinion/decision on a Paediatric investigation plan (PIP): Infigratinib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0331/2021
08/09/2022 Periodic safety update single assessment: Citalopram : List of nationally authorised medicinal products - PSUSA/00000779/202112
08/09/2022 Opinion/decision on a Paediatric investigation plan (PIP): Deucravacitinib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0325/2021
08/09/2022 Opinion/decision on a Paediatric investigation plan (PIP): Fenebrutinib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0319/2021
08/09/2022 Opinion/decision on a Paediatric investigation plan (PIP): Vatiquinone, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0318/2021
08/09/2022 Opinion/decision on a Paediatric investigation plan (PIP): Olumiant, baricitinib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0339/2021
08/09/2022 Other: Origio - Procedural steps and scientific information after initial consultation
08/09/2022 Referral: Procaine benzylpenicillin , Article 82, Under evaluation, 18/02/2022, 08/09/2022
08/09/2022 Template or form: QRD Appendix II - Medical Dictionary for Regulatory Activities terminology to be used in section 4.8 'undesirable effects' of the summary of product characteristics (Cover page)
08/09/2022 COVID-19 vaccine safety update: COVID-19 vaccines - Safety update: 8 September 2022
08/09/2022 Orphan designation: 18‐mer antisense oligonucleotide complementary to SCN1A mRNA, sodium salt for the: Treatment of Dravet syndrome, 24/02/2022, Positive
08/09/2022 Orphan designation: Elafibranor for the: Treatment of primary biliary cholangitis, 25/07/2019, Positive
08/09/2022 Human medicines European public assessment report (EPAR): Procysbi, mercaptamine bitartrate, Cystinosis, 05/09/2013, Orphan, 15, Authorised
08/09/2022 Other: Record of data processing activity for Interactive Regulatory Information System (IRIS) (public)
08/09/2022 Report: Final programming document 2022-2024
08/09/2022 Human medicines European public assessment report (EPAR): Ontozry, cenobamate, Epilepsy, 26/03/2021, Additional monitoring, 4, Authorised
07/09/2022 Periodic safety update single assessment: Hydromorphone : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001686/202111
07/09/2022 Periodic safety update single assessment: Hydromorphone : List of nationally authorised medicinal products - PSUSA/00001686/202111
07/09/2022 Other: European Medicine Agency's Data Protection Notice for the Interactive Regulatory Information System (IRIS)
07/09/2022 Opinion/decision on a Paediatric investigation plan (PIP): Kymriah, tisagenlecleucel, PM: decision on the application for modification of an agreed PIP, P/0215/2022
07/09/2022 Human medicines European public assessment report (EPAR): Tepadina, thiotepa, Hematopoietic Stem Cell Transplantation, 15/03/2010, 18, Authorised
07/09/2022 Periodic safety update single assessment: Bendamustine hydrochloride : List of nationally authorised medicinal products - PSUSA/00003162/202201
07/09/2022 Periodic safety update single assessment: Niflumic acid : List of nationally authorised medicinal products - PSUSA/00002157/202112
07/09/2022 Orphan designation: Asciminib for the: Treatment of chronic myeloid leukaemia, 24/03/2020, Positive
07/09/2022 Other: Speakers' biographies - Clinical Trials Information System (CTIS) bitesize talk: Notifications - Part 1
06/09/2022 Human medicines European public assessment report (EPAR): Zerbaxa, ceftolozane sulfate, tazobactam sodium, Bacterial Infections, 18/09/2015, 15, Authorised
06/09/2022 News and press releases: ECDC-EMA statement on booster vaccination with Omicron adapted bivalent COVID-19 vaccines
06/09/2022 Human medicines European public assessment report (EPAR): Jardiance, empagliflozin, Diabetes Mellitus, Type 2, 22/05/2014, 26, Authorised
06/09/2022 Human medicines European public assessment report (EPAR): GONAL-f, follitropin alfa, Anovulation; Reproductive Techniques, Assisted; Infertility, Female; Hypogonadism, 20/10/1995, 25, Authorised
06/09/2022 Human medicines European public assessment report (EPAR): Luveris, lutropin alfa, Ovulation Induction; Infertility, Female, 29/11/2000, 21, Authorised
06/09/2022 Human medicines European public assessment report (EPAR): Inhixa, enoxaparin sodium, Venous Thromboembolism, 15/09/2016, Biosimilar, 22, Authorised
06/09/2022 Periodic safety update single assessment: Botulinum toxin a - haemagglutinin complex : List of nationally authorised medicinal products - PSUSA/00000427/202112
06/09/2022 Human medicines European public assessment report (EPAR): Aspaveli, Pegcetacoplan, Hemoglobinuria, Paroxysmal, 13/12/2021, Orphan, Additional monitoring, 3, Authorised
06/09/2022 Agenda: Agenda of the CVMP meeting 6-8 September 2022
06/09/2022 Human medicines European public assessment report (EPAR): Fetcroja, cefiderocol sulfate tosilate, Gram-Negative Bacterial Infections, 23/04/2020, Additional monitoring, 4, Authorised